A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Sanofi147 sites in 1 country549 target enrollmentSeptember 2012

ConditionsType 1 Diabetes Mellitus

InterventionsHOE901-U300 (Insulin glargine new formulation)Lantus (Insulin glargine)

DrugsHOE901-U300 (Insulin glargine new formulation)Lantus (Insulin glargine)

Overview

Phase: Phase 3
Intervention: HOE901-U300 (Insulin glargine new formulation)
Conditions: Type 1 Diabetes Mellitus
Sponsor: Sanofi
Enrollment: 549
Locations: 147
Primary Endpoint: Change In HbA1c From Baseline to Month 6 Endpoint
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
Change of HbA1c from baseline to endpoint (scheduled Month 6)
Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

Detailed Description

The maximum study duration was up to approximately 54 weeks per participants: * Up to 2-week screening period * 6-month open-label comparative efficacy and safety treatment period * 6-month open-label comparative safety extension period * 48-hour post-treatment safety follow-up period

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

March 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

HOE901-U300

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

Intervention: HOE901-U300 (Insulin glargine new formulation)

Lantus

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Intervention: Lantus (Insulin glargine)

Outcomes

Primary Outcomes

Change In HbA1c From Baseline to Month 6 Endpoint

Time Frame: Baseline, Month 6

Secondary Outcomes

Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint(Month 6)
Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint(Baseline, Month 6)
Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint(Baseline, Month 6)
Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6(Month 6)
Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint(Baseline, Month 6)
Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint(Baseline, Month 6)
Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint(Baseline, Month 6)
Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint(Baseline, Month 6)
Percentage of Participants With HbA1c <7% at Month 6 Endpoint(Month 6)
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12(Up to Month 12)
Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint(Month 6)